Clinical Study of Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis

To Evaluate the Safety and Efficacy of Dental Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis Using Sodium Hyaluronate as a Parallel Control.

To evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate.

20 participants will receive low dose of dental pulp mesenchymal stem cells, 20 participants will receive high dose and another 20 participants will receive sodium hyaluronate

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: Low Dose of Mesenchymal stem cell; Biological: High Dose of Mesenchymal stem cell; Drug: Sodium Hyaluronate

Detailed Description

60 participants will receive to evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate and verify the basis of dental pulp mesenchymal stem cells in the treatment of primary knee osteoarthritis, and to explore a more effective and safe clinical treatment of knee osteoarthritis.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Changhai Hospital
    • Contact: Guangrong Song, Doctor; Phone Number: +86-13918384480; Email: songguangrong@cart-sh.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Complying with the diagnostic criteria for primary knee osteoarthritis revised by the American Rheumatological Association (1995), age 40-70 years, gender-free.
2. For patients with mild to moderate knee arthritis, the WOMAC score of knee joint was less than 120.
3. X-ray Kellgren-Lawrence was used to evaluate the grade I, II and III of osteoarthritis.
4. Fertility patients should take effective contraceptive measures until the end of follow-up. Fertility women should exclude the possibility of early pregnancy, that is, HCG negative test in early pregnancy.
5. Voluntary participation in this clinical study, can cooperate with doctors to carry out research, stop all medical measures for knee arthritis for more than 2 weeks, and sign the informed consent of patients.

Exclusion Criteria:

(1) Those with other diseases that may affect the knee joint, such as rheumatoid arthritis, ankylosing spondylitis, rheumatoid arthritis, gout and other rheumatic diseases, bone tumors, osteoporosis, bone tuberculosis or obvious history of acute trauma, resulting in meniscus injury, ligament rupture and vascular nerve injury; those with previous history of femur, tibial plateau, tibia and fibula fracture. The patients with gonarthritis, the patients with knee joint and surrounding skin infection were not cured.

2) Patients who have undergone surgery and other factors affecting the efficacy of the treatment. Patients with severe deformities or even deformities of the knee joint, who need surgical treatment. Patients who have received knee joint irrigation or arthroscopic examination within one year.

3) Patients with systemic cancer tendency or cancer and patients with systemic infection in active stage.

4) Patients with severe heart, lung, liver, kidney, blood system, endocrine system and immune deficiency, or abnormal laboratory biochemical indicators, namely: hemoglobin (Hb) < 9 g/dL, white blood cell (WBC) > 15 x 109/L, platelet (Pt) < 100 x 109/L, glutamic oxalate transaminase (AST) and alanine aminotransferase (ALT) > 1.5 times normal upper limit; serum creatinine > 1.5 times normal upper limit.

5) Physical history or clinical manifestations with bleeding tendency, including patients currently using anticoagulants.

6) Patients with uncontrollable epileptic seizures, psychosis or Alzheimer's disease who are unable to complete the scale.

7) Pregnant or lactating women, legal disabled patients (blind, deaf, dumb, mentally retarded, physically disabled), drug addiction and other adverse drug addiction.

8) Patients with contraindications or allergies were examined and treated in this study.

9) Those who have participated in other clinical studies within one month.

10) Researchers consider it inappropriate for patients to participate in this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose of Mesenchymal stem cell; Patients receiving intraarticular injection of low dose of mesenchymal stem cells.	Biological: Low Dose of Mesenchymal stem cell; Mesenchymal stem cell injection; Other Names: 1
Experimental: High Dose of Mesenchymal stem cell; Patients receiving intraarticular injection of high dose of mesenchymal stem cells.	Biological: High Dose of Mesenchymal stem cell; Mesenchymal stem cell injection; Other Names: 2
Active Comparator: Sodium Hyaluronate; Patients receiving intraarticular injection of Sodium Hyaluronate	Drug: Sodium Hyaluronate; Sodium Hyaluronate injection; Other Names: 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kellgren and Lawrence's rating	X-ray imaging was used to evaluate the degree of improvement in knee joint structure	12 month
WOMAC score	WOMAC score decreased	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of femoral surface of knee joint on MRI	Changes of volume of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI	12 month
relaxation time of femoral surface of knee joint on MRI	Changes of relaxation time (T1 condylar, T2 condylar, T2*) of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI	12 month

Collaborators and Investigators

• Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Dongbao Zhao, Doctor, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: KT005SH002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No